YY 0304-2009 English PDF (YY0304-2009)

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YY 0304-2009: Plasma sprayed hydroxyapatite coated-titanium dental implant
YY 0304-2009
YY
NATIONAL PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
C 33
Replacing YY 0304-1998
Plasma sprayed hydroxyapatite coated –
titanium dental implant
羟基磷灰石涂层 - 钛基牙种植体
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Requirements ... 6 
5 Test methods ... 9 
6 Marks, labels, packaging, transport, storage ... 11 
Foreword
This Standard mainly supplemented and modified the original standard content
according to the latest version of the relevant standard. The technical content
that this Standard shall contain is verified and supplemented in full compliance
with the provisions of International Standard ISO 10451-2002 "Dental implant
systems - Contents of technical file". All contents relating to plasma sprayed
hydroxyapatite coated - titanium dental implant are written in this new edition
according to the requirements of the international standard. The performance
requirements and test method of plasma sprayed hydroxyapatite coated
respectively and equivalently adopt ISO 13779.2-2000 "Implants for surgery-
Hydroxyapatite - Part 2. Coatings of hydroxyapatite", ISO 13779.3-2008
"Implants for surgery-Hydroxyapatite - Part 3. Chemical analysis and
characterization of crystallinity and phase purity" and ISO 13779.4-2002
"Implants for surgery-Hydroxyapatite - Part 4. Determination of coating
adhesive strength".
This Standard replaces the previous edition YY 0304-1998 "Plasma sprayed
hydroxyapatite coated titanium dental implant". Compared with the previous
edition, the main changes and reasons in this edition are as follows.
- in definitions, "dental implant" was specified as "plasma sprayed
hydroxyapatite coated - titanium dental implant" directly related in this
Standard, and added the definition of "endosseous implant"; their
definition are based on ISO/TR 11175.1993;
- the biological evaluation stated that the selection and evaluation of test
items were conducted in accordance with the relevant national standards
GB/T 16886 and the pharmaceutical industry standard YY/T 0268, and the
main requirements items and test methods were not listed item by item;
correspondingly, Annex A on biological testing method were also deleted;
- in the geometrical accuracy, added two items. neck surface roughness
and main important connection dimensions and tolerances; the testing
method of the geometric dimension accuracy part shall be no longer
specified, so as to adapt to the differences in the detection equipment
configuration of various production plants and the advanced methods and
instruments that are continuously emerging.
Chemical composition has the following changes.
- the HA content in the coating and the index of crystallinity were changed
to 95% and 45% according to the requirements of ISO 13779.2; added
"4.3.2.1.3 Atomic ratio of calcium and phosphorus";
- "4.3.2.2 Titanium chemical composition " was changed to "Chemical
Plasma sprayed hydroxyapatite coated –
titanium dental implant
1 Scope
This Standard specifies the technical requirements, test methods, product
classification, marks, labels, packaging, transport and storage for plasma
sprayed hydroxyapatite coated - titanium dental implant.
This Standard is applicable to the plasma sprayed hydroxyapatite coated -
titanium dental implant that is implanted in jawbone after the loss of a teeth.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 13810-2007, Wrought titanium and titanium alloy for surgical implants
GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation
and testing within a risk management process (GB/T 16886.1-2001,ISO
10993-1.1997, IDT)
YY/T 0268, Dentistry - Biological evaluation of medical devices used in
dentistry Part 1. Evaluation and test (YY/T 0268-2008, ISO/FDIS 7405.2008,
NEQ)
YY/T 0313-1998, Package, label, transport and storage for medical polymer
products
Pharmacopoeia of the People's Republic of China, 2005 Edition, Part II,
Annex XI "H sterility test method", Annex VIII "H heavy metal test method"
ISO 13779. 3-2008, Implants for surgery - Hydroxyapatite - Part 3. Chemical
analysis and characterization of crystallinity and phase purity
ISO 13779. 4-2002, Implants for surgery - Hydroxyapatite - Part 4.
D is the nominal size of the neck diameter, its limit deviation is ±0.1mm. L is the
nominal size of the root length, its limit deviation is ±0.2mm. The diameter and
length of each ladder segment shall also meet the limit deviation specified in
the design requirements.
4.2.4 Connection thread
For pile-removable dental implant, the connection thread shall give thread code
and thread tolerance zone code. The processing accuracy and the tolerance
zone shall ensure that the root and crown pile connection threads of crown-pile-
removable implant shall cooperate well.
4.2.5 Neck surface roughness
For a dental implant with a malleolus neck design, neck surface roughness.
Ra≤1.6µm.
4.2.6 Size and tolerance of important connection site
For pile-removable dental implant, the connection and structure of the
connection site shall be specified and comply with the specified concentricity,
size and tolerance requirements.
4.3 Physical and chemical properties
4.3.1 Appearance
The uncoated titanium surface of the dental implant shall be free from defects
such as cracks, hairless flaws, and scratches due to mechanical processing.
The root and crown pile of two-stage implant shall be well balanced. No visible
gaps and offsets between mating faces.
Hydroxyapatite coating is gray and white porous layer. The surface of the
coating is evenly covered and tightly covered with hydroxyl groups, without any
spots or cracks.
4.3.2 Chemical composition
4.3.2.1 Chemical composition of HA coating
4.3.2.1.1 HA content and crystallinity in coating
HA content ≥95%, HA crystallinity ≥45%.
4.3.2.1.2 Impurity element limit
Arsenic ≤ 3mg/kg, cadmium ≤ 5mg/kg, mercury ≤ 5mg/kg, lead ≤ 30mg/kg.
The total amount of heavy metals (in terms of lead) ≤ 50mg/kg.
also be different. This Standard does not make specific provisions so as to
adapt to different designs and advanced detection methods and detection
instruments that are constantly emerging.
5.2 Physical and chemical properties
5.2.1 Appearance
Visually inspected.
5.2.2 Chemical composition
5.2.2.1 Chemical composition of hydroxyapatite coating
5.2.2.1.1 HA content and crystallinity
The testing of HA content and crystallinity are performed in accordance with the
methods specified in ISO 13779.3.
5.2.2.1.2 Impurity element limit
The test method of trace impurities is in accordance with ISO 13779.3. The total
content of heavy metal elements is performed according to Pharmacopoeia of
the People's Republic of China, 2005 Edition, Par...